documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

224,736 rows where agency_id = "FDA" sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year >30

document_type 5

agency_id 1

  • FDA · 224,736 ✖
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2025-V-0353-0004 FDA Laser Light Show FDA-2025-V-0353 Amendment to variance from Something Good Other Amendment 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T20:51:22Z   0 0 09000064b92da646
FDA-2026-H-5254-0001 FDA DAB Civil Money Penalty; Gondal Enterprises LLC, d/b/a Exxon FDA-2026-H-5254 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T19:53:37Z   0 0 09000064b92da640
FDA-2026-H-5253-0001 FDA DAB Civil Money Penalty; Runlands LLC d/b/a Runland’s Grocery FDA-2026-H-5253 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T21:37:53Z   0 0 09000064b92da628
FDA-2025-P-7006-0009 FDA Requests that FDA declare that Dicyclomine Hydrochloride Tablets, 10 mg, is suitable for submission as an ANDA FDA-2025-P-7006 Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C. Other Grant of Petition 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T16:56:08Z   0 0 09000064b92d515d
FDA-2026-H-5252-0001 FDA DAB Civil Money Penalty; Rudraunsh, Inc., d/b/a United Mart FDA-2026-H-5252 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T18:15:10Z   0 0 09000064b92da5cd
FDA-2026-H-5255-0001 FDA DAB Civil Money Penalty; 6002 Gas Corp. d/b/a BP FDA-2026-H-5255 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T19:33:46Z   0 0 09000064b92db377
FDA-2026-H-5250-0001 FDA DAB Civil Money Penalty; Tornado 2 Tobacco and Vape Inc., d/b/a Tornado Tobacco & Vape FDA-2026-H-5250 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T21:35:08Z   0 0 09000064b92dadef
FDA-2026-H-5248-0001 FDA DAB Civil Money Penalty; Prayosha Inc. of Live Oak, d/b/a Live Oak Liquors FDA-2026-H-5248 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T22:57:37Z   0 0 09000064b92db36c
FDA-2025-P-6262-0052 FDA Requests that FDA, under FDCA §505G(b) (OTC monograph administrative order process), amend OTC Monograph M013 to update Drug Facts labeling for all over-the-counter acetaminophen-containing products. In the alternative, Petitioner asks FDA to initiate such an order on its own FDA-2025-P-6262 Interim Response Other Letter(s) 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T20:28:02Z   0 0 09000064b92dbaa6
FDA-2026-H-5251-0001 FDA DAB Civil Money Penalty; Chevron Stations Inc., d/b/a Chevron / Extra Mile FDA-2026-H-5251 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T18:18:45Z   0 0 09000064b92da5f9
FDA-2026-H-5249-0001 FDA DAB Civil Money Penalty; Antler Lake Store & Motel, Inc., d/b/a Antler Lake Store & Motel FDA-2026-H-5249 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T18:10:17Z   0 0 09000064b92da5b9
FDA-2025-N-0421-0002 FDA NOOH Proposal to Debar Oscar Bobo FDA-2025-N-0421 Oscar Bobo: Final Debarment Order Notice Statutory Debarment 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T17:48:54Z 2026-09767 1 0 09000064b92da9bd
FDA-2026-H-5256-0001 FDA DAB Civil Money Penalty; Mahadeva Inc. d/b/a Friendly Food Mart FDA-2026-H-5256 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T21:26:05Z   0 0 09000064b92db9f3
FDA-2026-H-5257-0001 FDA DAB Civil Money Penalty; Food Town Investments LLC d/b/a Food Town IGA FDA-2026-H-5257 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T23:01:41Z   0 0 09000064b92dadf5
FDA-2025-P-6024-0008 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Final Response Other Denial 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-16T01:50:33Z   0 0 09000064b92dc6f6
FDA-2026-P-5454-0009 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 7 - Smarr, M. M., et al. (2016). Urinary paracetamol and time-to-pregnancy. Human Reproduction, 31(9), 2119-2127. URL: https://pubmed.ncbi.nlm.nih.gov/27412248/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:39Z   0 0 09000064b92d5011
FDA-2026-P-5454-0014 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 12 - de Araújo-Ramos, A. T., et al. (2026). Differential disruption of gonadal development by DEHP and paracetamol in male and female Wistar rats. Reproductive Toxicology, 141, 109183. URL: https://doi.org/10.1016/j.reprotox.2026.109183 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:56Z   0 0 09000064b92d5031
FDA-2026-P-5454-0015 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 13 - Laursen, T. Q., et al. (2024). Maternal intake of paracetamol during pregnancy and biomarkers of male fecundity in young adult sons. Reproductive Toxicology, 127, 108626. URL: https://doi.org/10.1016/j.reprotox.2024.108626 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:00Z   0 0 09000064b92d5032
FDA-2022-V-0385-0004 FDA Laser Light Show FDA-2022-V-0385 Variance Renewal Application from Brant Parrish Other Application for Variance (VAR) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T18:02:11Z   0 0 09000064b92d6cc8
FDA-2026-P-5454-0002 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Acknowledgment Letter from FDA DMB to Americans for Scientific Integrity Other Acknowledgement Letter/Receipt 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T17:41:43Z   0 0 09000064b92d4fe9
FDA-2026-P-5454-0001 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Citizen Petition from Americans for Scientific Integrity Other Citizen Petition 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T17:41:38Z   1 0 09000064b92d4fe7
FDA-2025-P-6350-0004 FDA Requests that the FDA initiate notice-and-comment rulemaking to amend 21 CFR § 1271.90 to extend the existing regulatory exception for surplus cryopreserved embryos to surplus cryopreserved oocytes originally recovered for a woman’s own reproductive use FDA-2025-P-6350 Interim Response Letter from FDA CBER to Jack Weis Other Response(s) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T18:12:30Z   0 0 09000064b92d7d0a
FDA-2026-P-5454-0011 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 9 - Carlsen, L. N., et al. (2024). Overuse of analgesics can affect the fertility biomarker Anti-Müllerian Hormone in females. A translational study. Cephalalgia, 44(11). URL: https://doi.org/10.1177/03331024241290530 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:46Z   0 0 09000064b92d5013
FDA-2026-P-5454-0004 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 2 - Fisher, B. G., et al. (2016). Prenatal paracetamol exposure is associated with shorter anogenital distance in male infants. Human Reproduction, 31(11), 2642-2650. URL: https://pubmed.ncbi.nlm.nih.gov/27609981/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:41:58Z   0 0 09000064b92d500c
FDA-2026-P-5454-0013 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 11 - Wu, T., et al. (2024). Prenatal acetaminophen exposure and the developing ovary: time, dose, and course consequences for fetal mice. Food and Chemical Toxicology, 189, 114679. URL: https://doi.org/10.1016/j.fct.2024.114679 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:53Z   0 0 09000064b92d5030
FDA-2026-P-5578-0001 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Suitability Petition from Appco Pharma LLC Other Petition(s) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:17:53Z   1 0 09000064b92d8f5b
FDA-2026-H-5193-0001 FDA DAB Civil Money Penalty; Semo Gas Stations LLC d/b/a Cooter Browns / Exxon FDA-2026-H-5193 Complaint Other Complaint 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-15T00:35:04Z   0 0 09000064b92d79e2
FDA-2026-P-5578-0004 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Attachment 2 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:09Z   0 0 09000064b92d70f1
FDA-2026-P-5578-0005 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Attachment 3 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:14Z   0 0 09000064b92d70f2
FDA-2026-H-5184-0001 FDA DAB Civil Money Penalty; Tobacco Zone Inc., d/b/a Tobacco Zone FDA-2026-H-5184 Complaint Other Complaint 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T19:33:28Z   0 0 09000064b92d6ce9
FDA-2026-H-5191-0001 FDA DAB Civil Money Penalty; Nafii Group LLC d/b/a Morning Star Market / Marathon FDA-2026-H-5191 Complaint Other Complaint 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T20:05:30Z   0 0 09000064b92d6cee
FDA-2020-V-0476-0004 FDA Laser Light Show FDA-2020-V-0476 Variance Renewal Application from Andrew Stuart Other Application for Variance (VAR) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T18:05:51Z   0 0 09000064b92d76f8
FDA-2026-P-5454-0017 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 15 - Lee, C. Y., et al. (2023). Effects of acetaminophen on reproductive activities in male golden hamsters. Development & Reproduction, 27(1), 25-37. URL: https://doi.org/10.12717/DR.2023.27.1.25 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:26Z   0 0 09000064b92d5034
FDA-2026-P-5611-0003 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 attachment-1-orange-book-page Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:37:59Z   0 0 09000064b92d874f
FDA-2026-P-5454-0021 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 19 - Eletri, L., et al. (2026). Association between in utero exposure to acetaminophen and external genital tract malformations in boys and girls: a systematic review and meta-analysis. Human Reproduction, 41(3), 427-442. URL: https://doi.org/10.1093/humrep/deaf253 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:53Z   0 0 09000064b92d5038
FDA-2026-P-5454-0003 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 1 - Ernstsen, C., et al. (2026). Prenatal paracetamol modulates sexually dimorphic behaviour and steroidogenesis in adult male and female mice. Reproduction, 171(2). URL: https://doi.org/10.1093/reprod/xaag007 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:41:54Z   0 0 09000064b92d500b
FDA-2026-P-5454-0006 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 4 - Guzmán-Montemayor, A. J., et al. (2026). Prenatal, but not neonatal, paracetamol exposure disrupts neuroendocrine regulation of stress and emotional behavior in adult male rats. Physiology & Behavior, 308, 115261. URL: https://doi.org/10.1016/j.physbeh.2026.115261 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:16Z   0 0 09000064b92d500e
FDA-2026-P-5454-0007 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 5 - Górawski, F., et al. (2026). Sex-dependent effects of early-life paracetamol exposure on behavior and monoamines in the rat central nervous system. Chemico-Biological Interactions, 427, 111937. URL: https://doi.org/10.1016/j.cbi.2026.111937 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:31Z   0 0 09000064b92d500f
FDA-2026-P-5578-0002 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Acknowledgement Letter from FDA DMB to Appco Pharma LLC Other Acknowledgement Letter/Receipt 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:17:57Z   0 0 09000064b92d8f63
FDA-2026-P-5611-0004 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 attachment-2-rld-labeling Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:38:03Z   0 0 09000064b92d8750
FDA-2026-P-5611-0005 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 attachment-3-test-product-draft-labeling Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:38:07Z   0 0 09000064b92d8751
FDA-2026-P-5454-0005 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 3 - Lind, D. V., et al. (2017). Maternal use of mild analgesics during pregnancy associated with reduced anogenital distance in sons. Human Reproduction, 32(1), 149-155. URL: https://pubmed.ncbi.nlm.nih.gov/27852690/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:12Z   0 0 09000064b92d500d
FDA-2026-P-5454-0018 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 16 - Xu, M., et al. (2024). Association of acetaminophen use with perinatal outcomes among pregnant women: a retrospective cohort study with propensity score matching. BMC Pregnancy and Childbirth, 24, 268. URL: https://doi.org/10.1186/s12884-024-06480-5 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:29Z   0 0 09000064b92d5035
FDA-2026-P-5454-0023 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 21 - OFIRMEV (acetaminophen) Injection Package Insert. (2018). Mallinckrodt Hospital Products Inc. Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:44:02Z   0 0 09000064b92d503a
FDA-2026-P-5454-0020 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 18 - Rehfeld, A., et al. (2022). Human sperm cells can form paracetamol metabolite AM404 that directly interferes with sperm calcium signalling and function through a CatSper-dependent mechanism. Human Reproduction, 37(5), 922-935. URL: https://doi.org/10.1093/humrep/deac042 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:48Z   0 0 09000064b92d5037
FDA-2026-P-5611-0002 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc Other Acknowledgement Letter/Receipt 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:37:28Z   0 0 09000064b92d7cce
FDA-2026-P-3630-0006 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules, USP 0.8 mg FDA-2026-P-3630 Completeness Assessment Correspondence Other Assessment Document or Analysis 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T15:19:06Z   0 0 09000064b92d613f
FDA-2026-P-5454-0022 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 20 - Kougias, D. G., et al. (2025). A quantitative weight-of-evidence review of preclinical studies examining the potential developmental and reproductive toxicity of acetaminophen. Critical Reviews in Toxicology, 55(2), 179-226. URL: https://doi.org/10.1080/10408444.2024.2446471 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:58Z   0 0 09000064b92d5039
FDA-2026-P-5454-0010 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 8 - Nielsen, B. S., et al. (2025). Paracetamol disrupts early embryogenesis by cell cycle inhibition. Human Reproduction, 40(10), 1860-1876. URL: https://doi.org/10.1093/humrep/deaf116 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:42Z   0 0 09000064b92d5012
FDA-2026-P-5454-0019 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 17 - Zafeiri, A., et al. (2022). Maternal over-the-counter analgesics use during pregnancy and adverse perinatal outcomes: cohort study of 151,141 singleton pregnancies. BMJ Open, 12(5), e048092. URL: https://doi.org/10.1136/bmjopen-2020-048092 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:32Z   0 0 09000064b92d5036
FDA-2026-P-5454-0008 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 6 - Lecante, L. L., et al. (2022). Acetaminophen interferes with the first trimester human fetal ovary development in an ex vivo model. Journal of Clinical Endocrinology & Metabolism, 107(6), 1647-1661. URL: https://pubmed.ncbi.nlm.nih.gov/35147701/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:35Z   0 0 09000064b92d5010
FDA-2026-P-5454-0012 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 10 - Liu, F., et al. (2024). Maternal administration of acetaminophen affects meiosis through its metabolite NAPQI targeting SIRT7 in fetal oocytes. Antioxidants & Redox Signaling, 41, 93-109. URL: https://doi.org/10.1089/ars.2023.0270 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:50Z   0 0 09000064b92d502f
FDA-2026-P-5454-0016 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 14 - Andreasen, S. M., et al. (2025). Maternal urinary paracetamol concentrations and self-reported paracetamol use in mid-gestation: association to reduced anogenital distance in offspring from infancy to 9 years. Reproductive Toxicology, 135, 108946. URL: https://pubmed.ncbi.nlm.nih.gov/40374128/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:22Z   0 0 09000064b92d5033
FDA-2026-P-5611-0001 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 Suitability Petition from Senores Pharmaceuticals, Inc Other Petition(s) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:37:18Z   1 0 09000064b92d9592
FDA-2026-P-5578-0003 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Attachment 1 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:06Z   0 0 09000064b92d70f0
FDA-2026-N-4126-0001 FDA Azodicarbonamide (ADA); Request for Information FDA-2026-N-4126 Azodicarbonamide (ADA); Request for Information Notice Requests for Information (RFI) 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z 2026-07-14T03:59:59Z 2026-05-13T17:13:38Z 2026-09508 1 0 09000064b92d17fd
FDA-2026-H-4962-0001 FDA DAB Civil Money Penalty; Lincolnway, Inc. d/b/a Lincolnway Liquor & Bar FDA-2026-H-4962 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T16:11:53Z   0 0 09000064b92d2875
FDA-2026-N-0005-0003 FDA Public Seminar FDA-2026-N-0005 Reference 2 - Kalaria SN, TR Farchione, R Uppoor, M Mehta, Y Wang, and H Zhu, 2021, Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder, Journal of Clinical Pharmacology, 61: S117–S124, doi: 10.1002/jcph.1836. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:12Z   0 0 09000064b92d59a0
FDA-2018-N-4626-1057 FDA List of Bulk Drug Substances That May be Used to Compound Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations FDA-2018-N-4626 Nomination from Stokes Pharmacy Other Nomination 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T22:53:42Z   0 0 09000064b92a502f
FDA-2026-N-2526-0005 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Reference 3 - Codex General Standard for Food Additives 2025 Food Categories Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T17:52:48Z   0 0 09000064b92d40e8
FDA-2019-D-1536-0037 FDA Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework; Draft Guidance for Industry; Availability FDA-2019-D-1536 Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:23:30Z   1 0 09000064b92d0c28
FDA-2026-N-3098-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting FDA-2026-N-3098 Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting Notice 60 Day Proposed Information Collection 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z 2026-07-14T03:59:59Z 2026-05-13T16:56:28Z 2026-09543 1 0 09000064b92d4966
FDA-2026-N-2526-0002 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Reference List Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T17:52:37Z   0 0 09000064b92d40e5
FDA-2026-N-2526-0004 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Reference 2 - What We Eat in America Food Categories, available at https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/dmr-food-categories/. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T17:52:45Z   0 0 09000064b92d40e7
FDA-2026-H-4964-0001 FDA DAB Civil Money Penalty; Central Park Food, Corp. d/b/a Shell FDA-2026-H-4964 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T20:07:19Z   0 0 09000064b92d474c
FDA-2026-P-5453-0004 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Attachment 2 - de la Plaza Llamas et al. - Laparoscopic Removal of a Displaced Vertical Gastric Clip Causing Gastric Outlet Obstruction Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:05:03Z   0 0 09000064b92d58f6
FDA-2026-H-5121-0001 FDA DAB Civil Money Penalty; R & E Meat Market LLC d/b/a Ruben's Meat Market 3 FDA-2026-H-5121 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-14T00:04:07Z   0 0 09000064b92d4ee4
FDA-2026-H-5050-0001 FDA DAB Civil Money Penalty; RIA 24 LLC d/b/a Smoke City 3 FDA-2026-H-5050 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-14T00:06:15Z   0 0 09000064b92d4ce2
FDA-2026-H-5126-0001 FDA DAB Civil Money Penalty; Natural Food Deli, Inc. d/b/a Gourmet Deli FDA-2026-H-5126 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T20:18:06Z   0 0 09000064b92d58d5
FDA-2023-D-0608-0005 FDA Development of Local Anesthetic Drug Products With Prolonged Duration of Effect; Draft Guidance for Industry; Availability FDA-2023-D-0608 Development of Local Anesthetic Drug Products With Prolonged Duration of Effect; Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:22:13Z   1 0 09000064b92d0c40
FDA-2026-N-2526-0001 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Butylated Hydroxytoluene (BHT); Request for Information Notice Requests for Information (RFI) 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z 2026-07-14T03:59:59Z 2026-05-13T17:01:00Z 2026-09507 1 0 09000064b92d4931
FDA-2026-H-4823-0001 FDA DAB Civil Money Penalty; HotSpot Stores LLC d/b/a Ozark Hot Spot FDA-2026-H-4823 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T18:56:10Z   0 0 09000064b92d46ee
FDA-2026-H-4794-0001 FDA DAB Civil Money Penalty; Commerce Puff Zone Tobacco & Vape LLC d/b/a Puff Zone Tobacco & Vape FDA-2026-H-4794 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T20:54:18Z   0 0 09000064b92d44cd
FDA-2026-H-5053-0001 FDA DAB Civil Money Penalty; Grab 'N Go Mart LLC d/b/a Grab 'N Go Mart Smoke Shop FDA-2026-H-5053 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:02:35Z   0 0 09000064b92d4bbf
FDA-2026-N-0005-0004 FDA Public Seminar FDA-2026-N-0005 Reference 3 - Kalaria SN, TR Farchione, MV Mathis, M Gopalakrishnan, I Younis, R Uppoor, M Mehta, Y Wang, and H Zhu, 2020, Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia, Journal of Clinical Pharmacology, 60(7): 848–859, doi: 10.1002/jcph.1580. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:15Z   0 0 09000064b92d59a1
FDA-2019-N-0994-0230 FDA Modified Risk Tobacco Product Applications for VLN™ King and VLN™ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group Inc. FDA-2019-N-0994 Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc. Notice Request for Comments 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-15T09:00:24Z 2026-09544 1 0 09000064b92d47df
FDA-2021-N-0556-0026 FDA Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry; Availability FDA-2021-N-0556 Development of Non-Opioid Analgesics for Acute Pain; Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:20:57Z   1 0 09000064b92d0c73
FDA-1995-S-0036-0241 FDA Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 FDA-1995-S-0036 Public Disclosure from Boston Children's Hospital Other Public Disclosure 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T17:49:22Z   0 0 09000064b92d4423
FDA-2025-N-1600-0003 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 FDA-2025-N-1600 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 Notice 30 Day Proposed Information Collection 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z 2026-06-13T03:59:59Z 2026-05-13T17:17:21Z 2026-09448 1 0 09000064b92d4828
FDA-2026-N-2526-0003 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Reference 1 - Citizen Petition from Roger D. Middlekauff, dated December 23, 1986, available at regulations.gov in Docket No. FDA-2026-N-2526. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T17:52:41Z   0 0 09000064b92d40e6
FDA-2026-H-4965-0001 FDA DAB Civil Money Penalty; Super Deli 617, LLC d/b/a Super Delicatessen FDA-2026-H-4965 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T20:09:56Z   0 0 09000064b92d40a7
FDA-2026-R-5127-0001 FDA DAB No Tobacco Sale Order; Rapid Management Inc. d/b/a Roadrunner FDA-2026-R-5127 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T22:53:38Z   0 0 09000064b92d4bbc
FDA-2026-P-5453-0003 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Attachment 1 - Bonaldi et al. - 2024 - BariClip Outcomes and Complications from a Single-Center Experience Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:04:57Z   0 0 09000064b92d58f5
FDA-2026-H-5052-0001 FDA DAB Civil Money Penalty; LTHQ LLC d/b/a HQ Vape & Smoke FDA-2026-H-5052 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T20:19:23Z   0 0 09000064b92d4ce8
FDA-2023-D-1848-0023 FDA Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability FDA-2023-D-1848 Stimulant Use Disorders: Developing Drugs for Treatment; Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:18:07Z   1 0 09000064b92d0c8f
FDA-2025-D-0610-0125 FDA Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability FDA-2025-D-0610 Development of Non-Opioid Analgesics for Chronic Pain; Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:19:21Z   1 0 09000064b92d0c87
FDA-2026-N-4126-0003 FDA Azodicarbonamide (ADA); Request for Information FDA-2026-N-4126 Reference 2 - Codex General Standard for Food Additives, available at https://www.fao.org/gsfaonline/foods/index.html. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:35:23Z   0 0 09000064b92d66b5
FDA-2026-P-5453-0002 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Acknowledgement Letter from FDA DMB to Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS) Other Acknowledgement Letter/Receipt 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:04:37Z   0 0 09000064b92d5159
FDA-2026-H-5054-0001 FDA DAB Civil Money Penalty; State Street Mobil Incorporated d/b/a Mobil / State Street Car Care FDA-2026-H-5054 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:14:35Z   0 0 09000064b92d4ee9
FDA-2026-P-5453-0005 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Attachment 3 - Jacobs et al. - 2017 - A Vertically Placed Clip for Weight Loss: a 39-Month Pilot Study Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:05:09Z   0 0 09000064b92d5d02
FDA-2026-H-5125-0001 FDA DAB Civil Money Penalty; 2034 Best Gourmet Deli Inc. d/b/a Best 2034 Gourmet Deli FDA-2026-H-5125 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-14T00:06:58Z   0 0 09000064b92d599b
FDA-2026-N-0005-0001 FDA Public Seminar FDA-2026-N-0005 Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information Notice Requests for Information (RFI) 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z 2026-07-14T03:59:59Z 2026-05-13T17:06:21Z 2026-09533 1 0 09000064b92d48f3
FDA-2026-H-4827-0001 FDA DAB Civil Money Penalty; Big Boss IV, LLC, d/b/a Big Boss Stores / 76 FDA-2026-H-4827 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T19:16:50Z   0 0 09000064b92d4469
FDA-2026-H-4955-0001 FDA DAB Civil Money Penalty; All Thingz Exotic South, LLC d/b/a All Thingz Exotic South FDA-2026-H-4955 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T18:58:41Z   0 0 09000064b92d443b
FDA-2025-H-3115-0002 FDA DAB Civil Money Penalty; Sehgal Enterprises LLC, d/b/a AJ's One-Stop FDA-2025-H-3115 Amended Complaint Other Amendment 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T18:31:59Z   0 0 09000064b92d2a7a
FDA-2026-H-4952-0001 FDA DAB Civil Money Penalty; Zaidal Blue Sky Investments Corp d/b/a I Lava You Smoke Shop FDA-2026-H-4952 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T19:14:34Z   0 0 09000064b92d445b
FDA-2026-P-5453-0001 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Citizen Petition from Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS) Other Citizen Petition 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:00:37Z   1 0 09000064b92d5158
FDA-2026-H-5051-0001 FDA DAB Civil Money Penalty; Dollar Treat & More, Inc. d/b/a Dollar Treat & More FDA-2026-H-5051 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T20:57:05Z   0 0 09000064b92d44db
FDA-2026-H-4992-0001 FDA DAB Civil Money Penalty; Jusbelinda Grocery Corp. d/b/a Grocery Corp. FDA-2026-H-4992 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T19:45:07Z   0 0 09000064b92d3805
FDA-2026-N-0005-0002 FDA Public Seminar FDA-2026-N-0005 Reference 1 - Chen J, J Florian, W Carter, RD Fleischer, TS Hammerstrom, PR Jadhav, W Zeng, J Murray, and D Birnkrant, 2013, Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies, Gastroenterology, 144(7):1450–1455.e2, epub ahead of print March 5, 2013, doi: 10.1053/j.gastro.2013.02.039. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:08Z   0 0 09000064b92d599f

Next page

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;